Patel Minal R, Zhang Guanghao, Heisler Michele, Piette John D, Resnicow Kenneth, Choe Hae-Mi, Shi Xu, Song Peter
Department of Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
J Gen Intern Med. 2024 Oct;39(13):2415-2424. doi: 10.1007/s11606-024-08708-8. Epub 2024 Mar 11.
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
Randomized trial from 2019 to 2023.
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (p = 0.24). There were also no significant between-group differences in systolic blood pressure (p = 0.29), met social needs (p = 0.25), CRN (p = 0.18), and perceived financial burden (p = 0.31). In subgroup analyses, participants with household incomes 100-400% FPL (1.93 (SE = 0.76), p < 0.01), 201-400% FPL (1.30 (SE = 0.62), p < 0.04), and > 400% FPL (1.27 (SE = 0.64), p < 0.05) had significantly less A1c decreases compared to the control group.
On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups.
ClinicalTrials.gov ID NCT03950973, May 2019.
1型或2型糖尿病成人患者在有效进行糖尿病自我管理方面常常面临经济挑战及其他未得到满足的社会需求。
聚焦解决健康的社会经济决定因素的数字干预措施在改善糖尿病临床结局方面是否比常规护理更有效。
2019年至2023年的随机试验。
共有600名糖尿病成人患者，糖化血红蛋白（HbA1c）≥7.5%，且自我报告存在未得到满足的社会需求或来自医疗系统的经济负担，并被随机分为干预组或标准护理组。
CareAvenue是一种自动化电子健康干预措施，包含八个视频，旨在解决导致不良结局的未得到满足的社会需求。
主要结局指标为随机分组前、随机分组后6个月和12个月时测量的糖化血红蛋白。次要结局指标包括收缩压、报告的已满足的社会需求、与费用相关的治疗不依从性（CRN）以及经济负担。我们研究了主要效应以及预定义亚组间效应的差异。
78%的CareAvenue参与者完成了网站的一个或多个模块。在12个月的随访中，CareAvenue组与对照组在糖化血红蛋白变化方面无显著差异（p = 0.24）。在收缩压（p = 0.29）、已满足的社会需求（p = 0.25）、CRN（p = 0.18）和感知经济负担（p = 0.31）方面，两组之间也无显著差异。在亚组分析中，家庭收入为联邦贫困线（FPL）100 - 400%（1.93（标准误 = 0.76），p < 0.01）、201 - 400% FPL（1.30（标准误 = 0.62），p < 0.04）以及> 400% FPL（1.27（标准误 = 0.64），p < 0.05）的参与者与对照组相比，糖化血红蛋白降低幅度显著更小。
总体而言，与对照组参与者相比，CareAvenue参与者在降低糖化血红蛋白、满足需求、CRN或感知经济负担方面并未取得更好的效果。收入较高的CareAvenue参与者糖化血红蛋白降低幅度显著低于对照组。需要针对考虑为不同人群亚组量身定制方法的社会需求干预措施开展进一步研究。
ClinicalTrials.gov标识符NCT03950973，2019年5月。
